Research Feasibility

The Miami CTSI supports two feasibility committees for the Miller School of Medicine research enterprise. The (1) Research Feasibility Committee reviews industry-sponsored clinical research studies while the (2) COVID-19 Feasibility Committee reviews COVID-19 related studies.

The purpose of these committees is to optimize the allocation of institutional resources and effort, reduce duplicative studies, and improve the overall performance of clinical research at the Miller School of Medicine.

For each study type, please review the steps to submitting a feasibility intake form.

Industry-Sponsored Clinical Research Studies

Beginning September 1, 2022, all new industry-sponsored clinical research studies, will be reviewed for feasibility by the Miller School of Medicine (MSOM) Research Feasibility Committee (RFC) prior to IRB submission.

What do I need to do?

Study teams will be required to complete the Feasibility Intake Form for all new, industry-sponsored clinical research studies, prior to IRB submission and ORA contracting.

Who do I contact with questions?

If you have any questions, please feel free to contact the Research Feasibility Committee at [email protected].

Additional Information

Resources

Videos on Research Feasibility Assessment Tools – For more information, including training videos on how to perform a feasibility check/query/analysis using programs like URIDE or Epic SlicerDicer, click on the link for the Research Feasibility Assessment Tools. First time users will need to register for an account with your University of Miami email address. Once registered and/or logged in, click “Enroll Me” to view the video and PowerPoint training materials for how to use these feasibility tools.

Committee Members

Carl Schulman, MD, PhD (Chair) Surgery/Burn
Ivette Cejas, PhD (Co-Chair) Otolaryngology
Barbara J. Coffey, MD Psychiatry
Fernando Corrales-Medina, MD Pediatrics – Hematology
Kamil Detyniecki, MD Neurology – Epilepsy
Sakir Humayun Gultekin, MD Pathology
Philip D. Harvey, MD Psychiatry
Pasquale Patrizio, MD Obstetrics and Gynecology
Richard Preston, MD Medicine – Clinical Pharmacology
Sanoj Punnen, MD Urology
David Reis, PhD UHealth IT
Allan E. Rodriguez, MD Medicine  – Infectious Diseases

COVID-19 Feasibility

What do I need to do?
All investigators interested in conducting a COVID-19 related study must complete the COVID-19 study intake form before submitting the study to the HSRO and ORA.

The Feasibility Committee is made up of scientific and clinical experts at the Miller School of Medicine. The committee’s charge is to assess which studies have the best chance of benefiting current and future patients with the goal of improving the quality of research and to ensure that there are not duplicative studies with the same participant population.

Investigators will be notified of the Committee’s decision and recommendation.

Who do I contact with questions?
If you have any questions regarding the new COVID-19 Feasibility Committee, please email [email protected].

Committee Members

Maria Abreu, MD (Chair) Medicine/Gastroenterology
Jose Castro, MD Medicine/Infectious Diseases
Susanne Doblecki-Lewis, MD Medicine/Infectious Diseases
Elizabeth Franzmann, MD Otolaryngology/Head and Neck
Hayley Gershengorn, MD Medicine/Pulmonary
Richard A. Preston, MD Medicine/Clinical Pharmacology
Richard Silverman, MD Anesthesiology/Critical Care Medicine
Adam Wanner, MD Medicine/Pulmonary